Patent Case Summaries August 11, 2021

Patent Case Summaries | Week Ending August 6, 2021

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

GlaxoSmithKline LLC, et al. v. Teva Pharmaceuticals USA, Inc., Nos. 2018-1976, -2023 (Fed. Cir. (D. Del.) Aug. 5, 2021). Per curiam opinion before Moore, Newman, and Prost. Dissenting opinion by Prost. 

This case involved a GSK patent for administering a combination of a drug called “carvedilol” and an ACE inhibitor, a diuretic, and digoxin. Teva applied for FDA approval of its generic carvedilol, certifying that GSK’s patent was invalid, unenforceable, or not infringed. GSK then obtained a reissue patent adding a requirement that the drug combination is administered “to decrease a risk of mortality caused by congestive heart failure.” The FDA required Teva to amend its original carvedilol label (i.e., the “partial” label / purported “skinny” label) to include indication for treatment of heart failure (i.e., the “full” label). 

GSK sued Teva for induced infringement of the reissue patent. At trial, a jury found the patent valid and willfully infringed and awarded damages. The district court, however, granted Teva judgment as a matter of law (JMOL) of noninfringement. The court ruled that GSK failed to prove that “Teva’s alleged inducement, as opposed to other factors, actually caused the physicians to directly infringe.” The district court believed that only non-Teva factors caused doctors to prescribe generic carvedilol for infringing use, and thus substantial evidence did not support the verdict of induced infringement. GSK appealed, and Teva conditionally cross-appealed the damages verdict.

The Federal Circuit originally decided this appeal in October 2020. Teva then petitioned for rehearing, arguing that the decision could be broadly read to impose liability on ANDA filers that carve out patented uses when seeking approval to market generic drug products. Also, amici curiae “raised concerns about lack of clarity of [the] decision when the patented uses are carved out of the FDA-approved label.” The Federal Circuit thus “agreed to rehear this case to make clear how the facts of this case place it clearly outside the boundaries of the concerns expressed by amici.” 

The Federal Circuit withdrew its prior opinion and issued this new opinion, once again vacating the district court’s grant of JMOL of no induced infringement and reinstating the jury verdict. The majority explained that “this is a case in which substantial evidence supports a jury finding that the patented use was on the generic label at all relevant times and that, therefore, Teva failed to carve out all patented indications.” The Federal Circuit also sustained the damages verdict.

The Federal Circuit ruled that, at trial, “GSK provided substantial evidence that Teva’s partial label instructed the method of use claimed in the [reissue] patent and thus was not a skinny label.” The court concluded that “substantial evidence supports the finding that Teva’s partial label was evidence Teva instructed physicians to use its carvedilol in an infringing way,” and “such a label is evidence of intent to induce infringement.” After recounting the record evidence, the court concluded that “the jury had sufficient circumstantial evidence, in the form of labels, marketing materials, catalogs, press releases, and expert testimony, for it to conclude that Teva succeeded in influencing doctors to prescribe carvedilol for the infringing use.”

In a lengthy dissent, Judge Prost explained that Teva did not “intentionally encourage[] infringement”; rather, “Teva, by carving out everything that GSK said would infringe, was trying to avoid having its label encourage infringement.” In Judge Prost’s view, the court’s “law on this issue has gone awry.” She expressed three particular concerns. First, “the majority further weakens the intentional-encouragement prong of inducement by effectively eliminating the demarcation between describing an infringing use and encouraging that use in a label.” “Second, the majority defies basic tort law by eviscerating the causation prong of inducement.” “Third, the majority creates confusion for generics, leaving them in the dark about what might expose them to liability.”

View Opinion

Andra Group, LP v. Victoria’s Secret Stores, L.L.C., et al., No. 2020-2009 (Fed. Cir. (E.D. Tex.) Aug. 3, 2021). Opinion by Hughes, joined by Reyna and Mayer. 

Andra sued a number of entities for patent infringement in the Eastern District of Texas. The defendants filed a motion to dismiss for improper venue, arguing that Victoria’s Secret Stores, LLC did not commit acts of infringement in the district, and that the other defendants (the Non-Store Defendants) did not have regular and established places of business in the district.

The district court dismissed the Non-Store Defendants for improper venue, but allowed the suit to continue against Victoria’s Secret Stores. Andra elected to voluntarily dismiss Victoria’s Secret Stores, and the district court then dismissed all remaining claims without prejudice. Andra appealed the district court’s decision dismissing the Non-Store Defendants for improper venue.

The Federal Circuit affirmed. The court held that Andra failed to demonstrate that the Non-Store Defendants maintain regular and established places of business in the district. The Federal Circuit determined that employees of Victoria’s Secret Stores were not agents of the Non-Store Defendants, and therefore the Store locations were not regular and established places of business of the Non-Store Defendants. The Federal Circuit explained that the Non-Store Defendants do not exert the necessary degree of control over Victoria’s Secret Stores to constitute an agency relationship, and the Non-Store Defendants did not ratify Victoria’s Secret Stores’ locations as their own places of business.

View Opinion

Mondis Technology Ltd., et al. v. LG Electronics Inc., et al., No. 2020-1812 (Fed. Cir. (D.N.J.) Aug. 3, 2021). Opinion by Hughes, joined by Dyk and Prost.

The Federal Circuit dismissed an interlocutory appeal for lack of jurisdiction.

In the district court, a jury found that LG infringed two patent claims, that the claims were not invalid, and that LG’s infringement was willful, and awarded Mondis $45 million in damages. LG then filed several post-trial motions, including motions relating to infringement, invalidity, willfulness, and damages. 

In a September 2019 Order, the district court denied LG’s motions regarding infringement, invalidity, and willfulness. In an April 2020 Order, the district court granted LG’s motion for a new trial on damages. Following the April Order, in May 2020, LG filed notice of an interlocutory appeal challenging the issues decided in the September Order. Mondis then moved to dismiss the appeal as untimely, arguing that LG needed to file notice of appeal within thirty days of the September Order.

The Federal Circuit agreed with Mondis and dismissed the appeal. The Federal Circuit has jurisdiction to hear certain interlocutory appeals under 28 U.S.C. § 1292(c), which provides jurisdiction over an appeal of a judgment in a patent infringement action that is “final except for an accounting.” Under the court’s precedent, “a judgment is final except for an accounting when all liability issues have been resolved, and only a determination of damages remains.”

Because the liability issues were resolved in the September Order (leaving only the damages issues that were decided in the April Order), “LG had thirty days from the September Order to file notice of interlocutory appeal.” The Federal Circuit therefore dismissed the appeal for lack of jurisdiction.

The Federal Circuit explained that its interpretation of the statute is consistent with the Federal Rules, including Rule 4 of the Federal Rules of Civil Procedure. Additionally, the court noted that “interlocutory appeals are voluntary, and LG is not precluded from challenging the liability determinations of the district court under [the court’s] § 1295 jurisdiction once the damages determination is completed.”

View Opinion

Omni MedSci, Inc. v. Apple Inc., Nos. 2020-1715, -1716 (Fed. Cir. (N.D. Cal.) Aug. 2, 2021). Opinion by Linn, joined by Chen. Dissenting opinion by Newman. 

Omni filed a lawsuit in district court accusing Apple of infringing two patents. In response, Apple filed a motion to dismiss for lack of standing alleging that the University of Michigan, rather than Omni, owned the patents based on the University’s bylaws. Specifically, Apple alleged that the bylaws automatically transferred legal title to the patents from the inventor to the University such that the inventor had no rights to assign to Omni. 

The district court denied Apple’s motion to dismiss, ruling that the bylaws did not constitute a present automatic assignment of title but instead were a statement of a future intention to assign. Apple then filed an unopposed motion for certification of the question to the Federal Circuit, thus appealing the district court’s denial of the motion to dismiss.

The Federal Circuit affirmed the district court’s holding that the University of Michigan’s bylaws did not effectuate a present automatic assignment of an inventor’s patent rights. The Federal Circuit determined that Omni’s standing depended on whether it had an exclusionary right in the asserted patents. The Federal Circuit determined that the bylaws’ failure to include an active verbal expression of present execution was a substantive indication that a present automatic assignment was not intended. The Federal Circuit further determined that the parties’ past conduct did not change the interpretation of the language. 

Judge Newman dissented. In her view, the majority’s interpretation of the bylaws contravened the documents’ plain meaning and long-understood interpretation.

View Opinion

Meet the Authors
Media Contact
Alex Wolfe
Communications Director

This website uses cookies to improve functionality and performance. For more information, see our Privacy Statement. Additional details for California consumers can be found here.